Reported Apr 26, 2023 · Ongoing
Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip
- Lot codes and dates
1) UDI-DI 14953170353106Model HX-201LR-135Lot 1ZV 2) UDI-DI 14953170353113Model HX-201UR-135Lot 23V 3) UDI-DI 14953170353120Model HX-201UR-135Lot 24V 4) UDI-DI 14953170353168Model HX-201UR-135LLot 24V
- Amount recalled
- 65.9 boxes (373 pieces)
Where it was sold
- Nationwide
Why it was recalled
There have been complaints that the clip did not come out of the tube sheath during the procedure.
This product could cause temporary or reversible health problems — stop using it.
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